A Study to Learn About the Safety of BIIB122 Tablets and Whether They Can Slow the Worsening of Early-Stage Parkinson's Disease in Adults Between the Ages of 30 and 80
Completed · Phase 2 · Has a placebo group
Conditions studied: Parkinson Disease
In brief
In this study, researchers will learn more about BIIB122 in participants with early-stage Parkinson's disease (PD). The study will include adults aged 30 to 80 who were diagnosed with PD within 2 years of starting the study. The main objective of the study is to learn about the effect BIIB122 has on slowing down the worsening of PD symptoms. The main question researchers want to answer is: \- How long does it take for PD symptoms to worsen during BIIB122 treatment? Researchers will answer this and other questions by measuring the symptoms of PD over time using a variety of scoring tools. These include the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the modified Schwab and England Activities of Daily Living Scale (mSE-ADL). The MDS-UPDRS is used to measure symptoms of PD. It has 4 parts: Part I, II, III, and IV. Each part measures different aspects of motor and non-motor symptoms. The mSE-ADL measures a participant's ability to perform daily activities or personal chores. Researchers will also learn more about the safety of BIIB122. They will check participants for adverse events. Adverse events are unwanted health problems that may or may not be caused by the study drug. The study will be done as follows: * Participants will be randomly assigned to take either BIIBB122 or placebo. A placebo looks like the study drug but contains no real medicine. * Neither the researchers nor the participants will know if the participants are receiving BIIB122 or placebo. * Participants will take BIIB122 or placebo tablets by mouth once a day. * The treatment period for each participant will last between 48 and 144 weeks. * There will be a safety follow-up period for 2 weeks after the last dose of BIIB122. * In total, participants will have up to 29 study visits. * Participants will stay in the study for at least 1 year, up to about 3 years.
Key facts
- Study ID
- NCT05348785
- Run by
- Biogen
- People needed
- 650
- Starts
- 2022-04-19
- Expected to finish
- 2026-03-09
- Last updated by the study team
- 2026-06-04
Who can join
Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Banner Sun Health Research Institute — Sun City, Arizona, United States
- University of Southern California — Los Angeles, California, United States
- Cedars Sinai — Los Angeles, California, United States
- SC3 Research Group Inc. — Pasadena, California, United States
- University of California San Francisco (UCSF) — San Francisco, California, United States
- University of Colorado — Aurora, Colorado, United States
- CenExel Rocky Mountain Clinical Research — Englewood, Colorado, United States
- Invicro — New Haven, Connecticut, United States
- Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
- University of Miami — Miami, Florida, United States
- Adventist Health System/Sunbelt, Inc. — Orlando, Florida, United States
- USF Health Byrd Institute — Tampa, Florida, United States
- Hawaii Pacific Neuroscience, LLC — Honolulu, Hawaii, United States
- Northwestern University — Chicago, Illinois, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Azienda Ospedaliera Spedali — Brescia, Italy
- University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas, United States
- Boston University Medical Center — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Quest Research Institute — Farmington Hills, Michigan, United States
- Mount Sinai Beth Israel — New York, New York, United States
- Weill Medical College of Cornell University — New York, New York, United States
- Duke Movement Disorders Clinic — Durham, North Carolina, United States
- Mayo Clinic Arizona — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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